Nebulized azithromycin therapy for preventing bronchopulmonary dysplasia in preterm infants
THE EFFECT OF NEBULIZED AZITHROMYCIN AS AN ADJUVANT PREVENTIVE THERAPY FOR BRONCHOPULMONARY DYSPLASIA IN PRETERM INFANTS
This study is testing if giving nebulized azithromycin to very low birth weight preterm infants can help prevent bronchopulmonary dysplasia compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 7 Days to 28 Days |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 2 sites (Alexandria and 1 other locations) |
| Trial ID | NCT06584474 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of nebulized azithromycin in preventing bronchopulmonary dysplasia (BPD) in very low birth weight preterm infants compared to a placebo. The intervention involves administering azithromycin via nebulization to infants who are still requiring respiratory support by day 7 of life. The study will assess outcomes related to the incidence of BPD in this vulnerable population. Lung ultrasounds will also be utilized to monitor respiratory health throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born before 32 weeks of gestation with a birth weight under 1500 grams who require respiratory support at 7 days of life.
Not a fit: Patients who are older than 32 weeks gestation or have congenital heart diseases or major congenital malformations will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the incidence of bronchopulmonary dysplasia in very low birth weight preterm infants.
How similar studies have performed: While the use of nebulized azithromycin is a novel approach in this specific context, similar studies have shown promise in using antibiotics for respiratory conditions in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gestational age less than 32 weeks and birth weight less than 1500 g. 2. Infants who are still in need of respiratory support at day 7 of life (intubated, or by non-invasive mechanical ventilation, including CPAP and high-flow nasal cannula, or any form of oxygen therapy). Exclusion Criteria: * Gestational age ≥ 32 weeks. * Newborns with congenital cyanotic heart diseases. * Obvious major congenital malformations, known syndromes or chromosomal anomalies. * Infants with signs compatible with the diagnosis of necrotizing enterocolitis (NEC) in the first week of life. * Current use of steroids.
Where this trial is running
Alexandria and 1 other locations
- Alexandria University — Alexandria, Egypt (Not_yet_recruiting)
- Alexandria University — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: Marwa M Farag, phD
- Email: d.marwa.farag@gmail.com
- Phone: +201288681788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.